Home NDC 0597-0197 Praxbind
Product NDC 0597-0197
11-digit product format 005970197
Labeler code 0597
Product ID 0597-0197_9474d542-4726-4546-a768-10d418cdf5cc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name idarucizumab
Dosage form INJECTION
Route INTRAVENOUS
Labeler Boehringer Ingelheim Pharmaceuticals, Inc.
Application BLA761025
Marketing category BLA
Marketing start 2015-10-21
Substance IDARUCIZUMAB
Active strength 50 mg/mL
Pharmacologic classes Antibodies, Monoclonal, Humanized [CS], Humanized Monoclonal Antibody Fragment [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Praxbind IDARUCIZUMAB Boehringer Ingelheim Pharmaceuticals, Inc. c7400f8a-dcf4-a6df-6d07-983081b1bf34 2024-01-23 Warnings, Adverse reactions Exact identifier application number: BLA761025 ndc (product): 0597-0197
Additional Listing Data#
Finished product Yes
Brand name base Praxbind
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IDARUCIZUMAB 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 97RWB5S1U6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1716195 Internal RxNorm lookup 1716200 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0597-0197-05 Praxbind 2 in 1 CARTON INJECTION 2 8 0597-0197-05 Praxbind 50 mL in 1 VIAL, SINGLE-DOSE INJECTION 50 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0597-0197 PRAXBIND (IDARUCIZUMAB) INJECTION [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20240208_c7400f8a-dcf4-a6df-6d07-983081b1bf34.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761025 Praxbind idarucizumab 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0597-0197-05 00597019705 2 VIAL, SINGLE-DOSE in 1 CARTON (0597-0197-05) / 50 mL in 1 VIAL, SINGLE-DOSE 2015-10-21 0000-00-00 No No Current